Apparatus and methods for sealing vascular punctures

ABSTRACT

An apparatus for sealing a passage through tissue includes a bioabsorbable body disposed on a distal end of a handle device. The plug member includes a helical thread on its outer surface and the plug member and handle device include cooperating lumens communicating with a distal port. A sealing member is disposed within the plug member lumen. An obturator is inserted through the lumens until its distal tip extends beyond the plug member, the distal tip including a bleed back port. The plug member is threaded into a passage towards a blood vessel until the bleed back indicator identifies the location of the vessel with respect to the plug member. The plug member is released from the handle device, the handle device and obturator are withdrawn, and the sealing member seals the lumen. The plug member is left within the passage to seal the passage until the tissue heals.

[0001] This application is a continuation-in-part of application Ser.No. 09/738,431, filed Dec. 14, 2000, the disclosure of which isexpressly incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to apparatus and methodsfor sealing or closing passages through tissue, and more particularly todevices for sealing punctures or other openings communicating with bodylumens, such as blood vessels, and to apparatus and methods fordelivering such devices.

BACKGROUND

[0003] Catheterization and interventional procedures, such asangioplasty or stenting, generally are performed by inserting a hollowneedle through a patient's skin and muscle tissue into the vascularsystem. A guide wire may then be passed through the needle lumen intothe patient's blood vessel accessed by the needle. The needle may beremoved, and an introducer sheath may be advanced over the guide wireinto the vessel, e.g., in conjunction with or subsequent to a dilator. Acatheter or other device may then be advanced through a lumen of theintroducer sheath and over the guide wire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroduction of various devices into the vessel, while minimizing traumato the vessel wall and/or minimizing blood loss during a procedure.

[0004] Upon completion of the procedure, the devices and introducersheath may be removed, leaving a puncture site in the vessel wall.External pressure may be applied to the puncture site until clotting andwound sealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

[0005] Various apparatus have been suggested for percutaneously sealinga vascular puncture by occluding the puncture site. For example, U.S.Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe theuse of a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

[0006] Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

[0007] Staples and surgical clips have also been suggested for closingwounds or other openings in tissue. For example, U.S. Pat. Nos.5,007,921 and 5,026,390, issued to Brown, disclose staples that may beused to close a wound or incision. In one embodiment, an “S” shapedstaple is disclosed that includes barbs that may be engaged into tissueon either side of the wound. In another embodiment, a ring-shaped stapleis disclosed that includes barbs that project from the ring. Thesestaples, however, have a large cross-sectional profile and therefore maynot be easy to deliver through a percutaneous site to close an openingin a vessel wall.

[0008] In addition, skin seals have been proposed that may be threadedinto an opening in skin. For example, U.S. Pat. No. 5,645,565, issued toRudd et al., discloses a surgical plug that may be screwed into apuncture to seal the puncture. The surgical plug includes an enlargedcap and a threaded shaft that extends from the cap. During an endoscopicprocedure, the plug may be threaded into an opening through skin untilthe cap engages the surface of the skin. The plug is intended to sealthe opening communicating with a body cavity to prevent insufflationfluid from leaking from the cavity. Such plugs, however, may only beused at the surface of the skin, and may not be introduced throughtissue, for example, to seal an opening in the wall of a blood vessel orother subcutaneous region.

[0009] Accordingly, devices for sealing punctures or other passagesthrough tissue, e.g., an opening into a blood vessel, would beconsidered useful.

SUMMARY OF THE INVENTION

[0010] The present invention is directed to apparatus and methods forsealing or closing passages through tissue, such as puncturescommunicating with blood vessels or other body lumens.

[0011] In accordance with one aspect of the present invention, a devicefor sealing a passage through tissue is provided that includes a body,e.g., formed from bioabsorbable material, including a proximal end, adistal end, and a helical thread on an outer surface extending at leastpartially between the proximal and distal ends. The body includes alumen extending between the proximal end and a distal inlet port. Asealing member is disposed within the lumen that is expandable forsubstantially sealing the lumen from fluid flow therethrough.

[0012] In a first preferred embodiment, the sealing member includes amaterial that is expandable when exposed to fluid to substantially sealthe lumen, such as a foam and/or a bioabsorbable material. The sealingmember may be a valve or other device that is biased towards a firstconfiguration for substantially sealing the lumen from fluid flowtherethrough, and is movable to a second configuration for accommodatingintroduction of one or more devices through the lumen.

[0013] In a second preferred embodiment, the lumen includes a taperedportion that tapers in cross-section, and the sealing member is agenerally annular-shaped member disposed adjacent a wide end of thetapered portion of the lumen. The sealing member is movable into thetapered portion for substantially sealing the lumen from fluid flowtherethrough.

[0014] In accordance with another aspect of the present invention, anapparatus is provided for sealing a passage through tissue that includesa handle device or other elongate member and a plug member. The elongatemember has a proximal end, a distal end, and a lumen extending betweenthe proximal and distal ends. The plug member is disposed on the distalend of the elongate member, and includes a helical thread on its outersurface and a distal port therein in communication with the lumen.

[0015] Preferably, the plug member includes a passage therein extendingbetween the distal port and the lumen. A sealing member may be disposedin the passage for substantially sealing the passage from fluid flowtherethrough, such as that described above. In one embodiment, thepassage and lumen define a bleed back lumen for determining the locationof the plug member relative to a blood vessel or other body lumen.

[0016] In another embodiment, an obturator or other elongate member isinsertable through the lumen such that a distal end of the obturator isdisposed beyond the distal end of the plug member. The obturator mayinclude a location indicator for identifying when the distal end of theplug member is disposed adjacent a body lumen. The location indicatormay include a bleed back lumen in the obturator and a bleed back port onits distal tip, the bleed back port being in communication with thebleed back lumen. Alternatively, the location identifier may include anexpandable member on a distal tip of the obturator, the expandablemember being expandable when the distal tip is disposed within a bodylumen for providing tactile feedback of a location of the distal end ofthe plug member with respect to the body lumen.

[0017] Preferably, the plug member is releasable from the elongatemember. The elongate member may include an actuator for releasing theplug member from the distal end of the elongate member. Preferably,cooperating connectors are provided on the distal end of the elongatemember and on the plug member for releasably securing the plug member tothe distal end of the elongate member.

[0018] In accordance with yet another aspect of the present invention, amethod is provided for sealing a passage through tissue communicatingwith a body lumen using an apparatus, such as that described above.Generally, the apparatus includes an elongate member, and a plug memberdisposed on a distal end of the elongate member. The plug memberincludes an outer surface including a helical thread, and a bleed backindicator associated with a distal end of the plug member.

[0019] The plug member is inserted into the passage until the helicalthread begins to enter the passage. The elongate member may be rotatedin a first direction, thereby threading the plug member into the passageuntil the bleed back indicator enters the body lumen, whereupon fluidfrom the body lumen may enter the bleed back indicator to identify thelocation of the body lumen with respect to the plug member. If desired,rotation of the elongate member may be reversed, thereby withdrawing theplug member a predetermined distance relative to the body lumen.Thereafter, the plug member may be released from the elongate memberwithin the passage. Preferably, the plug member is formed frombioabsorbable material, and the plug member is left within the passageuntil it is absorbed by the tissue.

[0020] In a preferred embodiment, the elongate member includes a lumenextending from its proximal end through the plug member, and the bleedback indicator includes a bleed back port in the plug member, the bleedback port being in communication with the lumen. Alternatively, anobturator may be inserted through the lumen until a distal end of theobturator extends distally beyond the plug member, and the bleed backindicator may include a bleed back lumen in the obturator.

[0021] A sealing member may be provided in a lumen of the plug memberfor sealing the lumen, and consequently the bleed back port, from fluidflow therethrough. The sealing member may be an expandable material thatexpands when exposed to fluid. Alternatively, the sealing member may bea generally annular-shaped element that may be disposed adjacent a wideend of a tapered portion of the lumen. The annular-shaped may be movedor otherwise wedged into the tapered portion for substantially sealingthe lumen.

[0022] Other objects and features of the present invention will becomeapparent from consideration of the following description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023]FIG. 1A is an exploded perspective view of a first preferredembodiment of an apparatus for sealing a passage through tissue, inaccordance with the present invention.

[0024]FIG. 1B is a perspective view of the assembled apparatus of FIG.1A.

[0025]FIG. 2 is a detail of a distal end of the apparatus of FIGS. 1Aand 1B.

[0026] FIGS. 3A-3D are cross-sectional views showing a plug member onthe apparatus of FIGS. 1A and 1B being used to seal an opening in a wallof a blood vessel.

[0027]FIGS. 4A is an exploded perspective view of a second preferredembodiment of an apparatus for sealing a passage through tissue, inaccordance with the present invention.

[0028]FIG. 4B is a perspective view of the assembled apparatus of FIG.4A.

[0029]FIG. 5 is a side view of a third preferred embodiment of anapparatus for sealing a passage through tissue, in accordance with thepresent invention.

[0030]FIG. 6A is a cross-sectional side view of a fourth embodiment ofan apparatus for sealing a passage through tissue, including a plugmember with a sealing member within its lumen, in accordance with thepresent invention.

[0031]FIG. 6B is a cross-sectional detail of the plug member of FIG. 6A,taken along line 6B-6B, showing the sealing member in an openconfiguration.

[0032]FIG. 6C is a cross-sectional side view of the apparatus of FIG.6A, with the sealing member wedged into a tapered portion of the lumen.

[0033]FIG. 6D is a cross-sectional detail of the plug member of FIG. 6C,taken along line 6D-6D, showing the sealing member wedged into a closedconfiguration.

[0034] FIGS. 7A-7F are cross-sectional views showing an apparatus andmethod for delivering a plug member to seal a puncture communicatingwith a blood vessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Turning now to the drawings, FIGS. 1A, 1B, and 2 show a firstpreferred embodiment of an apparatus 10 for sealing a passage throughtissue, in accordance with the present invention. Generally, theapparatus 10 includes a plug member 12, an elongate shaft or handledevice 14, and an obturator 16.

[0036] The plug member 12 is a substantially rigid body, preferablyhaving a generally cylindrical shape, including a proximal end 20, adistal end 22, and an outer surface 30. The plug member 12 includes alumen 24 that extends between a proximal opening 26 and a distal openingor port 28.

[0037] The plug member 12 may be formed from a biocompatible material,e.g., a plastic, such as polyethylene or polyester. Preferably, the plugmember 12 is formed at least partially (and more preferably entirely)from bioabsorbable material, such as collagen, polyglycolic acids(PGA's), polyactides (PLA's), and the like, that may be at leastpartially absorbed by the patient's body over time. Alternatively, theplug member 12 may be a semi-rigid or flexible body or may have asubstantially flexible distal tip (not shown), e.g., to facilitateatraumatic insertion of the plug member 12 into the passage. In additionor alternatively, the plug member 12 may be tapered along its length,and/or the distal end 22 may be rounded to facilitate advancement of theplug member 12 into a passage through tissue.

[0038] In a preferred embodiment, the plug member 12 has a length of notmore than about ten millimeters (10 mm), and more preferably betweenabout one and ten millimeters (1-10 mm). The plug member 12 alsopreferably has a diameter of between about one and twenty millimeters(1-20 mm). Preferably, the length and diameter have a ratio that notmore than about two-to-one.

[0039] The plug member 12 generally includes a helical thread pattern18, including one or more helical threads, that extend at leastpartially between its proximal and distal ends 20, 22. Preferably, thethread pattern 18 extends completely to the distal end 22 of the plugmember 12, and may be tapered at the distal end 22 to facilitateintroduction into a passage through tissue (not shown). The helicalthread 18 is preferably substantially rigid and may have a substantiallysquare cross-section to facilitate sealing of a passage into which theplug member 12 is threaded. In a preferred embodiment, the helicalthread 18 is integrally formed on the outer surface 30 of the plugmember 12. For example, the plug member 12 and thread 18 may be formedby injection molding. Alternatively, the threads may be cut or otherwiseformed in the outer surface 30 of the plug member 12.

[0040] As best seen in FIG. 2 (in which the handle device 14 has beeneliminated for convenience), a sealing member 32 is provided within thelumen 24 for substantially sealing the lumen 24 from fluid flowtherethrough. In a preferred embodiment, the sealing member 32 has anannular shape, and is mounted within an annular recess 33 in the lumen24. The sealing member 32 is preferably formed from a material thatexpands when exposed to fluids, e.g., an expandable foam. Morepreferably, the sealing member 32 is also bioabsorbable, similar to theplug member 12 itself. Exemplary materials that may be appropriate foruse in the sealing member 32 and/or for the plug member 12 are disclosedin U.S. Pat. No. 6,224,630, the disclosure of which is expresslyincorporated herein by reference. Alternatively, the sealing member 32may be a valve (not shown) that is biased to substantially seal thelumen 24 from fluid flow, but may be opened to facilitate introductionof one or more devices, e.g., the obturator 16 therethrough, asdescribed further below.

[0041] In an alternative embodiment, the plug member 12 may include acavity (not shown) in the distal end 22. A material (also not shown) maybe provided in the cavity, such as extra-cellular matrix material, e.g.,intestinal, stomach, or bladder submucosa, collagen, aninfection-resistant material, and the like, that may promote hemostasisand/or healing of the tissue. Alternatively, such material may beotherwise detachably secured to the distal end 22 of the plug member 12,either within a cavity or across the distal end 22 without a cavity. Forexample, the material may be secured using a biodegradable adhesive or amechanical fastener, such as one or more clips (not shown).

[0042] Returning to FIGS. 1A and 1B, the handle device 14 has a proximalend 34 and a distal end 36, and defines a longitudinal axis 38 thatextends between the proximal and distal ends 34, 36. A lumen 40 alsoextends between the proximal and distal ends 34, 36, e.g., foraccommodating insertion of the obturator 16 therethrough. A handle 42may be provided on the proximal end 34 of the handle device 14 forfacilitating manipulation of the apparatus 10, e.g., to facilitaterotation of the apparatus 10 into a passage, as described below.

[0043] Preferably, the handle device 14 is a substantially rigid tubularmember, formed from a biocompatible material, e.g., plastic, such aspolyethylene or polyester, or metal, such as stainless steel. The handledevice 14 preferably has a cross-section that is substantially smallerthan a cross-section of the plug member 12, e.g., to minimize dilationof a passage into which the apparatus 10 is inserted.

[0044] At least one of the plug member 12 and the distal end 36 of thehandle device 14 include a connector. Preferably, the plug member 12 andthe distal end 36 of the handle device 14 include cooperating connectors(not shown) for releasably securing the plug member 12 to the handledevice 14, as described in application Ser. No. 09/738,431, incorporatedabove. Preferably, the cooperating connectors substantially couple theplug member 12 to the handle device 14 such that the plug member 12cannot move independently of the handle device 14, e.g., such that theplug member 12 may be rotated only by rotating the handle device 14.

[0045] For example, the plug member 12 may include a recess (not shown)in its proximal end 20 and the handle device 14 may include a mechanism,e.g., a frame and/or radially projecting fingers (not shown), forfrictionally engaging the wall of the recess. Alternatively, the recessmay include slots for positively receiving the mechanism on the handledevice 14. In a further alternative, the plug member 12 may include ahub (not shown) extending from its proximal end 20 and the handle device14 may include a mechanism for detachable securing the hub to the handledevice 14.

[0046] Preferably, the handle 42 includes an actuator (not shown) thatmay be activated to release the connectors securing the plug member 12to the handle device 14. For example, the actuator may include a buttoncoupled to a control rod or wire (not shown) that extends through thehandle device 14 to its distal end 36. Upon depression of the button,the control rod may be moved, thereby disengaging the connector on thehandle device 14 from the mating connector on the plug member 12. Inanother alternative, the distal end 36 of the handle device 14 and theplug member 12 may include mating threads (not shown) so that the handledevice 14 may be rotated with respect to the plug member 12 to releasethe plug member 12. In this embodiment, the mating threads should windhelically in the same direction as the thread pattern 18 on the plugmember 12 to ensure that the plug member 12 is not released prematurelyfrom the handle device 14.

[0047] The obturator 16 is an elongate member, preferably having aproximal end 44 and a substantially atraumatic and/or flexible distaltip 46. An inlet or bleed back port 48 is provided on the distal tip 46,and a bleed back lumen 50 extends from the inlet port 48 to the proximalend 44. The proximal end 44 may include an outlet port 52, which mayinclude any conventional structure for detected or observing fluidpassing from the back bleed lumen 50.

[0048] The obturator 16 has a size and shape for insertion through thelumen 40 of the handle device 14 and through the lumen 24 of the plugmember 12. Once the obturator 16 is fully received through the handledevice 14, the distal tip 46 of the obturator 16 may extend beyond thedistal end 22 of the plug member 12, as shown in FIG. 1B. The obturator16 and the handle device 14 may include cooperating detents (not shown)for securing the obturator 16 once it is fully received through thehandle device 14 and plug member 12. The detents may substantiallypermanently or releasably couple the obturator 16 to the handle device14.

[0049] In alternative embodiments, an expandable member (not shown) maybe provided on or adjacent the distal tip 46 of the obturator 16, inaddition to or instead of the bleed back port and lumen 48, 50. Theexpandable member may be expandable, e.g., when the distal tip isdisposed within a body lumen, for providing tactile feedback of alocation of the distal end of the plug member with respect to the bodylumen. The expandable member may be a balloon, one or more expandablewings, such as those disclosed in application Ser. No. 09/732,835, filedDec. 7, 2000, or a helical tether device, such as that disclosed inapplication Ser. No. ______, entitled “Apparatus and Methods forProviding Tactile Feedback to Position a Closure Device,” filed on thesame day as the present application (attorney docket no. 260/100). Thedisclosures of these applications and any other references cited thereinare expressly incorporated herein by reference.

[0050] Turning to FIGS. 3A-3D, during use, the apparatus 10 may be usedto seal and/or close a passage through tissue 96, such as a puncture 92communicating with a blood vessel 90 or other body lumen. The puncture92 may be used to provide percutaneous access to the vessel 90. Forexample, the puncture 92 may facilitate performing an endovascularprocedure within a patient's vasculature, such as angioplasty, stenting,atherectomy, and the like, or may otherwise provide access via thevessel 90 to a region within the patient's body.

[0051] Upon completion of the procedure, any instruments, such as anintroducer sheath (not shown), may be removed from the vessel 90 andpuncture 92. If a guidewire 102 is used during the procedure, theguidewire 102 may be removed before delivering the plug member 12, orpreferably, the guidewire 102 may be used to guide the plug member 12into position, as described below.

[0052] Initially, the apparatus 10 is assembled as shown in FIG. 1B,i.e., the plug member 12 is connected to the handle device 14, and theobturator 16 is inserted through the handle device 14 and plug member12. The apparatus 10 may then be introduced into the puncture 92, forexample, initially by inserting the distal tip 46 of the obturator 16into the puncture 92. If the guidewire 102 is in place, generally asshown, the guidewire 102 may be backloaded into a guidewire lumen (notshown) in the obturator 16 in a conventional manner before inserting thedistal tip 46 into the puncture 92.

[0053] As the obturator 16 is advanced into the puncture 92 (e.g., overthe guidewire 102), the plug member 12 is inserted into the puncture 92,as shown in FIG. 3A. Because of the thread pattern 18, the handle device14 is then rotated in a first direction to thread the plug member 12into the puncture 92. Consequently, the outer surface 30 and threadpattern 18 engage tissue 96 surrounding the puncture 92, therebysubstantially sealing the puncture 92 from fluids, such as blood, withinthe vessel 90. The apparatus 10 may then be rotated in a first directionabout its longitudinal axis 38 to thread the plug member 12substantially atraumatically deeper into the puncture 92.

[0054] Turning to FIG. 3B, as the plug member 12 is advanced, the threadpattern 18 may facilitate advancement of the plug member 12 throughlayers of tissue towards the vessel 90. For example, the tissue 96 mayinclude one or more intermediate layers of fascia 99 or other tissuestructures disposed between layers of fat. The fascia layer 99 may berelatively thin, yet resilient and tough, and therefore it may bedifficult to advance a device axially through the layer 99 withoutdeflecting the layer 99 towards the vessel 90. Because of the threadpattern 18, a plug member 12 in accordance with the present inventionmay be threaded or screwed through the fascia layer 99 towards thevessel 90. This may substantially reduce the risk of the fascia layer 99being deflected towards the vessel 90 as the plug member 12 is advancedtowards the vessel 90, thereby minimize deflection of the plug member 12away from the vessel 90 once released within puncture 92 that mayotherwise occur if the fascia layer 99 is compressed towards the vessel90.

[0055] When the plug member 12 is advanced into the puncture 92, thedistal tip 46 of the obturator 16 eventually passes through the wall 98of the vessel 90, whereupon the bleed back port 48 becomes exposed tofluid, i.e., blood, within the vessel 90. Because of internal bloodpressure, the fluid enters the bleed back port 48, passes through thebleed back lumen 50 (not shown in FIGS. 3A-3D), and exits the outletport 52 (as represented by drops 54), thereby providing a visualindication that the vessel 90 has been attained. Because of the relativelengths of the plug member 12, the handle device 14, and the obturator16, this visual indication provides feedback on the location of thedistal end 22 of the plug member 12 relative to the vessel 90, as willbe appreciated by those skilled in the art. The relative lengths may bepredetermined such that the plug member 12 is at a preferred deploymentdepth when the bleed back indication is observed. For example, thedeployment depth may place the plug member 12 in close proximity to thevessel 90, e.g., without exposing the distal end 22 within the vessel90.

[0056] Preferably, the relative lengths may be such that the apparatus10 needs to be counter-rotated to attain the preferred deployment depth.For example, bleed back may occur when the plug member 12 is within orin close proximity to the vessel 90, as shown in FIG. 3B. Rotation ofthe apparatus 10 may then be reversed, i.e., in a second directionopposite the first direction, to withdraw the plug member 12 apredetermined distance relative to the vessel 90, as shown in FIG. 3C.Because of the known pitch of the thread pattern 18, the distance thatthe plug member 12 is moved relative to the vessel 90 may be relateddirectly to the number of rotations and/or partial rotations that theapparatus 10 is counter-rotated.

[0057] Once the desired deployment location is attained, the plug member12 may be released from the handle device 14. The obturator 16 may bewithdrawn from the plug member 12 and handle device 14 either before orafter releasing the plug member 12. The sealing member 32 (not shown,see FIG. 2) preferably substantially seals the lumen (not shown, seeFIG. 2) within the plug member 12 to prevent fluid within the vessel 90from passing therethrough to leak from the puncture.

[0058] Preferably, as explained above, the sealing member 32 is amaterial that expands when exposed to fluid. For example, as theobturator 16 is withdrawn, fluid, e.g., blood, may flow proximallythrough the lumen 24 in the plug member 12, e.g., until it encountersthe sealing member 32. Although a relatively small amount of fluid maypass beyond the sealing member 32, the sealing member 32 may expandsubstantially due to the fluid contact until it substantially seals thelumen. Alternatively, the sealing member 32 may be a valve that may opento accommodate the obturator 16, but may automatically close uponwithdrawal of the obturator 16.

[0059] Finally, as shown in FIG. 3D, the handle device 14 and theguidewire 102 (if still in place) may be withdrawn, leaving the plugmember 12 in place to substantially seal the puncture 92. If the plugmember 12 is bioabsorbable, it may remain within the puncture 92 as thetissue heals, thereby allowing the wall 98 of the vessel 90 and tissue96 surrounding the passage 92 to at least partially heal before the plugmember 12 is absorbed. Alternatively, the plug member 12 may beretrieved once the tissue between the plug member 12 and the vessel 90has substantially healed, as described in the application incorporatedabove.

[0060] Turning to FIGS. 4A and 4B, another embodiment of an apparatus110 is shown that includes a plug member 112 and a handle device 114.The plug member 112 includes a body, preferably formed frombioabsorbable material, including a proximal end 120 and a distal end122. A helical thread pattern 118 extends along an outer surface 130 ofthe plug member 112 at least partially between the proximal and distalends, similar to the embodiment described above. In addition, the plugmember 112 includes a lumen 124 and a sealing member 132 disposed withinthe lumen 124, similar to the embodiment described above.

[0061] The handle device 114 is an elongate member having an enlargedportion 134 and a reduced portion 136 defining a shoulder 138therebetween. The enlarged portion 134 may include a handle 142 on theproximal end 140. The reduced portion 136 has a size for insertionthrough the lumen 124 of the plug member 112 and terminates in a distaltip 146 that may be substantially atraumatic and/or flexible, similar tothe obturator distal tip described above. A bleed back port 148 isprovided in the distal tip 146 that communicates with a bleed back lumen150 that extends to an outlet port 152 in the proximal end 140.

[0062] As shown in FIG. 4B, the reduced portion 136 may be inserted intothe lumen 124 until the distal tip 146 extends beyond the distal end 122of the plug member 112 and/or the shoulder 138 abuts the proximal end120 of the plug member 112. Alternatively, the shaft of the handledevice 114 may have a substantially uniform cross-section, similar tothe reduced portion 134, and a raised portion (not shown) may beprovided on the shaft, e.g., an annular ridge against which the plugmember 112 may abut. Thus, the shoulder 138 or other raised portion maylimit proximal movement of the plug member 112 relative to the handledevice 114.

[0063] Preferably, the plug member 112 and the handle device 114 includecooperating elements (not shown) for coupling the plug member 112 to thehandle device 114, i.e., to prevent rotation of the plug member 112relative to the handle device 114. For example, all or a portion of thereduced portion 136 of the handle device 114 may have a noncircularcross-section, and all or a mating portion of the lumen 124 may have acomplementary noncircular cross-section. Alternatively, cooperatinglongitudinal slots and tabs and the like may be provided on the reducedportion 136 and within the lumen 124 of the plug member 114. Thus, whenthe reduced portion 136 is fully inserted through the lumen 124,rotation of the plug member 112 may be coupled to rotation of the handledevice 114. In a further alternative, the plug member 112 and the handledevice 114 may include connectors that may releasably couple the plugmember 112 to the handle device 114, similar to the embodiment describedabove.

[0064] The apparatus 110 may be used to seal and/or close a passagethrough tissue, such as a puncture communicating with a blood vessel orother body lumen (not shown), similar to the embodiment described above.Upon completion of a procedure accessed via the puncture, anyinstruments may be removed from the vessel and puncture, although aguidewire (not shown) may remain, similar to the embodiment describedabove. The apparatus 110 may be assembled as shown in FIG. 4B, i.e.,with reduced portion 134 of the handle device 114 fully inserted intothe plug member 112. The distal tip 146 may be inserted into thepuncture, e.g., over a guidewire (not shown) if still in place withinthe puncture, until the plug member 112 is inserted into the puncture92.

[0065] The apparatus 110 may then be rotated to thread the plug member112 into the puncture such that the outer surface 130 and thread pattern118 engage tissue surrounding the puncture to substantially seal thepuncture. When the distal tip 146 enters the vessel, the bleed back port148 becomes exposed to blood within the vessel. Because of internalblood pressure, fluid within the vessel enters the port 148, passesthrough the bleed back lumen 150, and exits the outlet port 152, therebyproviding a visual indication that the vessel has been attained.

[0066] If desired, rotation of the apparatus 110 may then be reversed towithdraw the plug member 112 a predetermined distance relative to thevessel. The plug member 112 may then be released from the handle device114. The handle device 114 may then be withdrawn from the plug member112 (and the guidewire, if still present). Preferably, the reducedportion 134 of the handle device 114 may simply be withdrawn from withinthe lumen 124, without requiring disengagement of connectors, which maysimplify construction of the handle device 114 compared to theembodiment described above. As the reduced portion 134 is withdrawn fromthe lumen 124, the sealing member 132 becomes exposed to fluid passingthrough the lumen 124. Preferably, as explained above, the sealingmember 132 expands when exposed to the fluid to substantially seal thelumen 124 from subsequent fluid flow. Alternatively, the sealing member132 may be a valve or an element that may controllably opened or closed(not shown).

[0067] Turning to FIG. 5, yet another embodiment of an apparatus 210 isshown that includes a plug member 212 and a handle device 214. The plugmember 212 includes a body, preferably formed from bioabsorbablematerial, including a proximal end 220, a distal end 222, and a helicalthread pattern 218 that extends along an outer surface 230 at leastpartially between the proximal and distal ends 220, 222, similar to theembodiment described above. In addition, the plug member 212 includes alumen 224 including an inlet or bleed back port 248 and a sealing member(not shown) disposed within the lumen 224. Alternatively, the lumen 224may have a sufficiently small cross-section that a sealing member maynot be necessary.

[0068] The handle device 214 has a proximal end 234 and a distal end236, and defines a longitudinal axis 238 that extends between theproximal and distal ends 234, 236. A lumen 240 also extends between theproximal and distal ends 234, 236. A handle 242 may be provided on theproximal end 234 of the handle device 214 for facilitating manipulationof the apparatus 210, e.g., to facilitate rotation of the apparatus 210into a passage, similar to the embodiments described above. An outletport 252 is provided on the proximal end 234, e.g., in the handle 242,that communicates with the lumen 240. Preferably, the handle device 214is a substantially rigid elongate shaft formed from biocompatiblematerial. The handle device 214 preferably has a cross-section that issubstantially smaller than a cross-section of the plug member 212,similar to the embodiments described above.

[0069] The plug member 212 and the distal end 236 of the handle device214 generally include cooperating connectors (not shown) for releasablysecuring the plug member 212 to the handle device 214, similar to thefirst embodiment described above. Preferably, the cooperating connectorssubstantially couple the plug member 212 to the handle device 214 suchthat the plug member 212 cannot move independently of the handle device214, e.g., such that the plug member 212 may be rotated only by rotatingthe handle device 214.

[0070] Preferably, the handle 242 includes an actuator (not shown) thatmay be activated to release the connectors securing the plug member 212to the handle device 214. For example, the actuator may include a buttoncoupled to a control rod or wire (not shown) that extends through thehandle device 214 to its distal end 236. Upon depression of the button,the control rod may be moved, thereby disengaging the connector on thehandle device 214 from the mating connector on the plug member 212.

[0071] Before use, the plug member 212 may be coupled to the distal end236 of the handle device 114. Once the plug member 212 is attached tothe distal end 236, the lumen 224 in the plug member 212 communicateswith the lumen 240 in the handle device 214.

[0072] The apparatus 210 may be used to seal and/or close a passagethrough tissue, similar to the embodiments described above. Afterperforming a procedure accessed via the puncture, the distal end 236 ofthe plug member 212 may be inserted into the puncture. The apparatus 210may then be rotated to thread the plug member 212 deeper into thepuncture. When the distal end 236 of the plug member 212 enters thevessel, the bleed back port 248 becomes exposed to blood within thevessel, causing fluid within the vessel to enter the port 248, passthrough the lumens 224, 240, and exit the outlet port 252, therebyproviding a visual indication that the vessel has been attained.

[0073] If desired, rotation of the apparatus 210 may then be reversed towithdraw the plug member 212 a predetermined distance relative to thevessel. The plug member 212 may then be released from the handle device214. The handle device 214 may then be withdrawn, leaving the plugmember 212 in place to,substantially seal the puncture.

[0074] If the plug member 212 includes a sealing member, the sealingmember is exposed to fluid passing through the lumen 224, causing thesealing member to expand when exposed to fluid contact to substantiallyseal the lumen 224 from subsequent fluid flow. Alternatively, if nosealing member is provided, the lumen may be sufficiently small suchthat hemostasis may still occur. The lumen 224 may begin to seal on itsown or, if necessary, external pressure may be applied to the punctureto promote hemostasis.

[0075] Turning to FIGS. 6A-6D, yet another embodiment of an apparatus310 is shown that includes a plug member 312 and a handle device 314.The plug member 312 includes a body, preferably formed frombioabsorbable material, including a proximal end 320 and a distal end322. A helical thread pattern 318 extends along an outer surface 330 ofthe plug member 312 at least partially between the proximal and distalends 320, 322, similar to the embodiments described above.

[0076] In addition, the plug member 312 includes a lumen 324 thatextends between a proximal opening 326 and a distal opening 328generally parallel to a longitudinal axis 338. The lumen 324 includes atapered portion 325 that tapers towards the distal end 322. The lumenmay include a proximal portion 324 a and a distal portion 324 b oneither side of the tapered portion 325 that may be substantially uniformin cross-section. Thus, the distal opening 328 may be substantiallysmaller than the proximal opening 326, e.g., corresponding to therespective portions of the tapered portion 325. In addition, the plugmember 312 may include an annular recess 327 disposed concentricallyaround the proximal opening 326.

[0077] A sealing member 332 is disposed in an open position adjacent thewide end of the tapered portion 325 of the lumen 324. The sealing member332 is a generally annular-shaped member, preferably a coil of materialincluding one or more overlapping layers, which may be formed from abiocompatible, and preferably a bioabsorbable material, similar to theplug member 312 itself. Alternatively, the sealing member 332 may be anenclosed ring that may be formed from semi-rigid or flexible material.In its open position, the proximal portion 324 a of the lumen 324 issubstantially open, i.e., the sealing member 332 does not generallyobstruct the lumen 324. The sealing member 332 is movable distally intothe tapered portion 325 to become compressed or wedged therein, therebydefining a closed position for substantially sealing the lumen 324 fromfluid flow therethrough.

[0078] The handle device 314 includes an outer carrier tube 334, and aninner delivery tube 336, the inner tube 336 being coaxially and/orslidably disposed within the outer tube 334. The handle device 314 mayinclude a handle and/or actuator (not shown) on a proximal end of thehandle device 314 for manipulating the handle device 314 and/or forcontrolling movement of the inner tube 336 relative to the outer tube334. A distal end 340 of the outer tube 334 may be received in theannular recess 327 to couple the plug member 312 to the handle device314. The distal end 340 may frictionally engage a wall of the recess327, e.g., providing a desired resistance to removing the distal end 340from the recess 327. In addition or alternatively, the distal end 340and/or the plug member 312 may include one or more connectors (notshown), similar to the embodiments described above.

[0079] A distal end 342 of the inner tube 336 preferably has a size forbeing slidably received into the proximal portion 324 a of the lumen324. Preferably, when the distal end 340 of the outer tube 334 isdisposed within the recess 327, the distal end 342 of the inner tube 336extends into the proximal portion 324 a of the lumen 324 in closeproximity, e.g., contacting, the sealing member 332. The inner tube 336preferably includes a lumen 344 that communicates with the lumen 324,more preferably the distal portion 324 b of the lumen 324. Thus, thelumens 344, 324 may provide a bleed back lumen, similar to theembodiments described above.

[0080] During use, the apparatus 310 is assembled by inserting thedistal end 340 of the outer tube 334 into the recess 327 and the distalend 342 of the inner tube 336 in the proximal portion 324 a of the lumen324, as shown in FIGS. 6A and 6B. The plug member 312 is inserted into apassage communicating with a blood vessel or other body lumen (notshown), and threaded through the tissue towards the vessel, e.g., byrotating the apparatus 310 in a first direction. When the distal end 322of the plug member 312 enters the vessel, fluid may flow into the distalopening 328, through the lumens 324, 344 to a proximal outlet port orother bleed back indicator (not shown) on the handle device 314. Ifdesired, the apparatus 310 may be counter-rotated in a second directionuntil the plug member 312 is disposed at a desired location within thepassage.

[0081] The inner tube 336 may then be advanced distally relative to theouter tube 334, thereby engaging the sealing member 332 and forcing itdistally into the tapered portion 325 of the lumen 324. Because of itsinherent flexibility and/or because of its coil shape, the sealingmember 325 may compress and/or otherwise become wedged into the taperedportion 325, thereby substantially sealing the lumen 324 from fluid flowtherethrough, as shown in FIGS. 6C and 6D. The plug member 312 may thenbe released from the handle device 314, e.g., by withdrawing the outertube 336 (without rotating it to unthread the plug member 312) and/or byreleasing connectors securing the plug member 312 to the distal end 340of the outer tube 334. The handle device 314 may then be withdrawn formthe passage, leaving the plug member 312 in place, similar to theembodiments described above.

[0082] Turning to FIGS. 7A-7D, an apparatus 410 is shown that includes aplug member 412 and an elongate shaft or handle device 414. The plugmember 412 may be formed from biocompatible and/or bioabsorbablematerial, similar to the embodiments described above. The plug member412 includes a proximal end 420, a distal end 422, and an outer surface430, and a lumen 424 that extends between the proximal and distal ends420, 422. The plug member 412 generally includes a helical threadpattern 418, including one or more helical threads, that extend at leastpartially between its proximal and distal ends 420, 422. A sealingmember 432 may be provided within the lumen 424, such as those describedabove.

[0083] The handle device 414 has a proximal end 434 and a distal end436, and defines a longitudinal axis 438 that extends between theproximal and distal ends 434, 436. In one embodiment, the handle device414 is tubular, and includes a lumen 440 extending between the proximaland distal ends 434, 436, the lumen 440 communicating with the lumen 424when the plug member 412 is attached to the distal end 434 of the handledevice 414. A handle 442 may be provided on the proximal end 434 of thehandle device 414 for facilitating manipulation of the apparatus 410,e.g., to facilitate rotation of the apparatus 410 into a passage.

[0084] The handle device 414 may be have a cross-section that issubstantially smaller than a cross-section of the plug member 412, e.g.,to minimize dilation of a passage into which the apparatus 410 isinserted. The plug member 412 and/or the distal end 436 of the handledevice 414 may include cooperating connectors (not shown) for releasablysecuring the plug member 412 to the handle device 414, as describedabove. Preferably, the handle 442 includes an actuator (also not shown)that may be activated to release the connectors securing the plug member412 to the handle device 414. Alternatively, the handle device 414 mayhave a cross-section defining a portion of a circle, e.g., a “C” shape,or may include one or more elongate shafts (not shown) that releasablyconnect to the plug member 412.

[0085] In addition, the plug member 412 and the handle device 414include a bleed back device for providing a visual indication when thedistal end 422 of the plug member 412 is disposed within a blood vessel90 or other body lumen. For example, as shown, the handle device 414 mayinclude a bleed back lumen 452 that extends between the proximal anddistal ends 434, 436. An outlet port 45, a transparent tube (not shown)or other device may be provided on the proximal end 434 of the handledevice 414 that communicates with the bleed back lumen 452. The plugmember 412 may include a bleed back port 454 that extends from thedistal end 422 to the bleed back lumen 452. For example, the bleed backport 454 may be a separate lumen (not shown) extending between theproximal and distal ends 420, 422 of the plug member 412.

[0086] Alternatively, the bleed back port 454 may be a groove extendingalong the lumen 424 of the plug member 412, as shown in FIGS. 7B-7E. Inaddition or alternatively, the bleed back lumen 452 in the handle device414 may be a groove (not shown) extending along the lumen 440 betweenthe proximal and distal ends 434, 436 of the handle device 414. Thegroove(s) may define a substantially enclosed passage when the apparatus410 is received over an introducer sheath 416 or other elongate member.

[0087] The apparatus 410 may be used in conjunction with an introducersheath 416 or other elongate member, having a proximal end 444 and adistal end 446. The sheath 416 may include a tapered and/orsubstantially atraumatic distal end 446 having a size for insertionthrough a puncture into a body lumen 90. The sheath 416 may include alumen 450 that extends between the proximal and distal ends 444, 446,the lumen 450 having a size to accommodate insertion of one or moredevices therethrough. The sheath 416 may include a seal (not shown),e.g., in the lumen 450 adjacent the proximal end 444 to substantiallyseal the lumen 450, yet accommodate devices (not shown) therethrough.

[0088] The apparatus 410 may be attachable to the sheath 416 at any timeduring a procedure, e.g., such that the plug member 412 and handledevice 414 may slide along the sheath 416. Alternatively, the apparatus410 may be substantially permanently, but slidably, attached to thesheath 416.

[0089] With particular reference to FIG. 7A, initially, the sheath 416may be introduced into a puncture or other passage 92 communicating witha blood vessel or other body lumen 90. The distal end 446 may beintroduced over a guidewire, a trocar, and/or a dilator (all not shown)until the distal end 446 is disposed in or adjacent to the vessel 90, asis well known to those skilled in the art. One or more instruments ordevices (not shown) may be advanced through the lumen 450 into thevessel 90 to perform a procedure at a location within the patient's bodyaccessed by the vessel 90. For example, an endovascular procedure may beperformed within a patient's vasculature, such as angioplasty, stenting,atherectomy, and the like.

[0090] As shown in FIG. 7B, upon completing the procedure, any devicesmay be removed from the lumen 450, and the plug member 412 may bedelivered into the passage 92 using the apparatus 410. With theapparatus 410 assembled, as shown, the apparatus 410 may be introducedinto the passage 92 over the sheath 416, i.e., by inserting the proximalend 444 of the sheath 416 into the lumen 424 in the plug member 412 andthrough the lumen 440 in the handle device 414.

[0091] For example, the distal end 422 of the plug member 412 may beinserted into the passage 92 until the thread pattern 418 begins toengage tissue 96 surrounding the passage 92. Then, as best seen in FIG.7C, the handle device 414 may be rotated in a first direction (indicatedby exemplary arrow) to thread the plug member 412 into the passage 92over the sheath 414. Consequently, the outer surface 430 and/or threadpattern 418 of the plug member 412 may substantially engage tissue 96surrounding the passage 92, thereby substantially sealing the passage 92from fluids, such as blood, within the vessel 90.

[0092] Turning to FIG. 7C, as the plug member 12 is advanced, the distalend 422 of the plug member 412 may eventually pass through the wall 98of the vessel 90, whereupon the bleed back port 454 may become exposedto fluid, i.e., blood, within the vessel 90. Because of internal bloodpressure, the fluid enters the bleed back port 454, passes through thebleed back lumen 452, and exits the outlet port 456 (as represented bydrops 458), thereby providing a visual indication that the vessel 90 hasbeen reached.

[0093] As shown in FIG. 7D, the apparatus 410 may be counter-rotated towithdraw the plug member 412 away from the wall 98 of the vessel 90. Forexample, bleed back may occur when the plug member 412 is within or inclose proximity to the vessel 90, as shown in FIG. 7C. Rotation of theapparatus 410 may then be reversed, i.e., in a second direction oppositethe first direction (indicated by exemplary arrow), to withdraw the plugmember 412 a predetermined distance relative to the vessel 90, as shownin FIG. 7D. Because of the known pitch of the thread pattern 418, thedistance that the plug member 412 is moved relative to the vessel 90 maybe related directly to the number of rotations and/or partial rotationsthat the apparatus 410 is counter-rotated.

[0094] Once the desired deployment location is attained, the sheath 416may be removed, as shown in FIG. 7E. Alternatively, the sheath 416 maybe withdrawn earlier, e.g., when the distal end 422 of the plug member412 is advanced into the vessel 90, or even earlier. As shown, thesealing member 432 may expand to substantially seal the lumen 424 in theplug member 412, similar to the embodiments described above. Forexample, the sealing member 432 may automatically expand when exposed tofluid, e.g., passing through the lumen 424. Alternatively, the sealingmember 432 may be expanded to substantially seal the lumen 424, eitherby an actuator or by compression of the sealing member 432 (not shown),similar to the embodiments described above.

[0095] If desired, the bleed back port 454, e.g., if a separate lumen(not shown) from the lumen 424, may also include a sealing member (alsonot shown) for substantially sealing the bleed back port 454 from fluidflow therethrough, similar to the sealing members described above.

[0096] When the plug member 412 is disposed at a desired location withinthe passage 92 and/or once hemostasis is obtained, the plug member 412may be released from the handle device 414. The handle device 414 (andsheath 416 if still within the passage 92) may be withdrawn from thepassage 92. As shown in FIG. 7F, the plug member 412 may remain in placeto substantially seal the passage 92, e.g., until the plug member 412 isabsorbed by the patient's body. Alternatively, the plug member 412 maybe retrieved once the tissue between the plug member 412 and the vessel90 has substantially healed, as described above.

[0097] While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

What is claimed is:
 1. A device for sealing a passage through tissue,comprising: a bioabsorbable body comprising a proximal end, a distalend, the body comprising a lumen extending between the proximal end anda distal inlet port; and a sealing member disposed within the lumen thatis expandable across the lumen for substantially sealing the lumen fromfluid flow therethrough.
 2. The device of claim 1, wherein the sealingmember comprises a material that is expandable when exposed to fluid tosubstantially seal the lumen.
 3. The device of claim 2, wherein thematerial comprises an expandable gel foam.
 4. The device of claim 1,wherein the sealing member comprises an annular-shaped member.
 5. Thedevice of claim 1, wherein the sealing member comprises a bioabsorbablematerial.
 6. The device of claim 1, wherein the sealing member is biasedtowards a first configuration for substantially sealing the lumen fromfluid flow therethrough, and is movable to a second configuration foraccommodating introduction of one or more devices through the lumen. 7.The device of claim 1, further comprising a connector on the proximalend of the body for detachably securing the body to a delivery device.8. The device of claim 1, further comprising an elongate shaft extendingfrom the proximal end of the body.
 9. The device of claim 1, wherein thebody has a length of not more than about ten millimeters.
 10. The deviceof claim 1, wherein the body has a diameter and a length, the diameterbeing not more than about twice the length.
 11. A device for sealing apassage through tissue, comprising: a bioabsorbable body comprising aproximal end, a distal end, the body comprising a lumen extendingbetween a proximal port and a distal port, the lumen comprising atapered portion that tapers in cross-section; and a sealing membercomprising a generally annular-shaped member disposed adjacent a wideend of the tapered portion of the lumen, the sealing member beingmovable into the tapered portion for substantially sealing the lumenfrom fluid flow therethrough.
 12. The device of claim 11, wherein thesealing member comprises a material that is expandable when exposed tofluid to substantially seal the lumen.
 13. The device of claim 11,wherein the sealing member comprises a coil of material.
 14. The deviceof claim 11, wherein the sealing member comprises a flexible materialthat may be wedged into the tapered portion.
 15. The device of claim 11,wherein the sealing member comprises a bioabsorbable material.
 16. Thedevice of claim 11, further comprising a connector on the proximal endof the body for detachably securing the body to a delivery device. 17.The device of claim 11, further comprising an elongate shaft extendingfrom the proximal end of the body.
 18. The device of claim 11, whereinthe body has a length of not more than about ten millimeters.
 19. Anapparatus for sealing a passage through tissue, comprising: an elongatemember having a proximal end, a distal end, and a lumen extendingbetween the proximal and distal ends; and a plug member disposed on thedistal end of the elongate member, the plug member comprising a distalport therein in communication with the lumen, the plug member having across-section larger than a cross-section of the elongate member. 20.The apparatus of claim 19, wherein the plug member comprises a passagetherein extending between the distal port and the lumen.
 21. Theapparatus of claim 20, further comprising a sealing member disposed inthe passage for substantially sealing the passage from fluid flowtherethrough.
 22. The apparatus of claim 21, wherein the sealing membercomprises a material that is expandable when exposed to fluid forsubstantially sealing the passage.
 23. The apparatus of claim 21,wherein the sealing member is biased towards a first configuration forsubstantially sealing the passage from fluid flow therethrough, and ismovable to a second configuration for accommodating introduction of oneor more devices through the passage.
 24. The apparatus of claim 21,wherein the sealing member comprises a valve.
 25. The apparatus of claim21, wherein the lumen includes a tapered portion reducing incross-section, and wherein the sealing member comprises a generallyannular-shaped member disposed adjacent a wide end of the taperedportion of the lumen, the annular-shaped being movable into the taperedportion for substantially sealing the lumen.
 26. The apparatus of claim25, further comprising a activation element coupled to the elongatemember, the activation element extending into the lumen of the plugmember for moving the sealing member into the tapered portion forsubstantially sealing the lumen.
 27. The apparatus of claim 20, furthercomprising an elongate member insertable through the lumen such that adistal end of the elongate member is disposed beyond the distal end ofthe plug member.
 28. The apparatus of claim 27, wherein the distal endof the elongate member comprises a location indicator for identifyingwhen the distal end of the plug member is disposed adjacent a bodylumen.
 29. The apparatus of claim 28, wherein the elongate membercomprises a tubular member including a bleed back lumen, and wherein thelocation indicator comprises a bleed back port on the distal end of thetubular member, the bleed back port being in communication with thebleed back lumen.
 30. The apparatus of claim 28, wherein the locationidentifier comprises an expandable member, the expandable member beingexpandable when the distal end is disposed within a body lumen forproviding tactile feedback of a location of the distal end of the plugmember with respect to the body lumen.
 31. The apparatus of claim 27,wherein the elongate member comprises an obturator including asubstantially atraumatic distal tip.
 32. The apparatus of claim 27,further comprising a valve in the passage for substantially sealing thepassage yet accommodating insertion of the elongate member therethrough.33. The apparatus of claim 19, wherein the plug member is releasablefrom the elongate member.
 34. The apparatus of claim 33, wherein theelongate member comprises an actuator for releasing the plug member fromthe distal end of the elongate member.
 35. The apparatus of claim 33,further comprising cooperating connectors on the distal end of theelongate member and on the plug member for releasably securing the plugmember to the distal end of the elongate member.
 36. The apparatus ofclaim 33, wherein the plug member comprises an interior cavity, andwherein the elongate member comprises an engagement element extendingfrom the distal end thereof for insertion into the cavity, theengagement element being expandable and collapsible for engaging anddisengaging an interior wall of the plug member, thereby selectivelysecuring the plug member to and releasing the plug member from thedistal end of the elongate member, respectively.
 37. The apparatus ofclaim 33, wherein the plug member comprises bioabsorbable material. 38.A method for sealing a passage through tissue communicating with a bodylumen using an apparatus comprising an elongate member, a plug memberdisposed on a distal end of the elongate member, and a bleed backindicator associated with a distal end of the plug member, the methodcomprising: inserting the plug member into the passage; advancing theelongate member, thereby advancing the plug member into the passageuntil the bleed back indicator enters the body lumen, whereupon fluidfrom the body lumen may enter the bleed back indicator to identify thelocation of the body lumen with respect to the plug member; andwithdrawing the plug member a predetermined distance relative to thebody lumen.
 39. The method of claim 38, further comprising releasing theplug member from the elongate member within the passage.
 40. The methodof claim 39, wherein the plug member comprises a bioabsorbable material,and wherein the method further comprises leaving the plug member withinthe passage until it is absorbed by the tissue.
 41. The method of claim38, wherein the body lumen comprises a blood vessel, and wherein theelongate member is advanced until the plug member substantially seals atleast one of the passage and a wall of the blood vessel.
 42. The methodof claim 41, further comprising: leaving the plug member within thepassage for sufficient time for hemostasis to occur; and removing theplug member from the passage.
 43. The method of claim 41, wherein thestep of advancing the elongate member comprises advancing the plugmember through one or more intermediate layers of tissue towards thevessel.
 44. The method of claim 43, wherein the one or more intermediatelayers of tissue comprises a layer of fascia.
 45. The method of claim38, wherein the elongate member includes a lumen extending from itsproximal end through the plug member.
 46. The method of claim 45,wherein the bleed back indicator comprises a bleed back port in the plugmember, the bleed back port being in communication with the lumen. 47.The method of claim 45, further comprising inserting an obturatorthrough the lumen until a distal end of the obturator extends distallybeyond the plug member.
 48. The method of claim 47, wherein the bleedback indicator comprises a bleed back lumen in the obturator.
 49. Themethod of claim 38, further comprising introducing one or moreinstruments through the passage to perform a procedure before insertingthe plug member into the passage.
 50. A method for sealing a passagethrough tissue communicating with a body lumen using an apparatuscomprising an elongate member, a plug member disposed on a distal end ofthe elongate member, and a lumen extending proximally from a distal portin the plug member, the method comprising: inserting the plug memberinto the passage until the helical thread begins to enter the passage;advancing the elongate member, thereby advancing the plug member intothe passage until the distal port enters the body lumen, whereupon fluidfrom the body lumen may enter the distal port to identify the locationof the body lumen with respect to the plug member; and activating asealing member in the lumen, thereby substantially sealing the lumenfrom fluid flow therethrough.
 51. The method of claim 50, furthercomprising withdrawing the plug member a predetermined distance relativeto the body lumen.
 52. The method of claim 50, further comprisingreleasing the plug member within the passage.
 53. The method of claim50, wherein the sealing member comprises a material that is expandableupon exposure to fluid, and wherein the activating step comprisesexposing the sealing member to fluid when the distal port enters thebody lumen.
 54. A method for sealing a passage through tissuecommunicating with a body lumen, the method comprising: providing anelongate member extending through the passage into the body lumen;advancing a plug member over the elongate member until an outer surfaceof the plug member begins to engage tissue surrounding the passage;advancing the plug member into the passage until a distal port in theplug member enters the body lumen, whereupon fluid from the body lumenmay enter the distal port to identify that plug member has entered thebody lumen; and withdrawing the elongate member from the passage,leaving the plug member within the passage to substantially seal thepassage.
 55. The method of claim 54, further comprising withdrawing theplug member a predetermined distance relative to the body lumen.
 56. Themethod of claim 54, further comprising activating a sealing memberwithin the lumen of the plug member, thereby substantially sealing thelumen from fluid flow therethrough.
 57. The method of claim 54, whereinthe plug member is disposed on a distal end of a handle device.
 58. Themethod of claim 57, further comprising releasing the plug member fromthe distal end of the handle apparatus within the passage.
 59. Themethod of claim 54, wherein the elongate member comprises an introducersheath, and wherein the method further comprises inserting one or moredevices through the introducer sheath into the body lumen.
 60. Themethod of claim 54, wherein the step of advancing the elongate membercomprises advancing the plug member through one or more intermediatelayers of tissue towards the body lumen.
 61. The method of claim 60,wherein the one or more intermediate layers of tissue comprises a layerof fascia.